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Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth

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ClinicalTrials.gov Identifier: NCT03327103
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Johns Hopkins University
Virginia Commonwealth University
Information provided by (Responsible Party):
Randy A. Jones, University of Virginia

Study Description
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Brief Summary:
Prostate cancer is a commonly diagnosed cancer, and is the second leading cause of cancer deaths among men in the U.S. The subgroup of men with advanced prostate cancer is particularly vulnerable to difficult choices for treatment because of the nature of their disease and having limited options. This study will test the use of an innovative Registered Nurse-Community Patient Navigator team delivered interactive mHealth decision aid for patients with advanced prostate cancer to help facilitate informed shared decisions about anti-cancer treatment that affects their quality of life.

Condition or disease Intervention/treatment Phase
Decision Support Techniques Behavioral: CHAMPION Not Applicable

Detailed Description:
Many patients with advanced prostate cancer along with their decision partners/ proxies (DPP) struggle with complex treatment decisions, such as when to start, change, or stop cancer directed treatment. Despite the utility of decision aids (DAs) to address decisional conflict, little is known about treatment decision-making for advanced cancers. The study's primary aim is to test the effects of a theory- based mHealth DA (CHAMPION) administered by Registered Nurse (RN)-Community Patient Navigator (CPN) teams to advanced prostate cancer patients and decision partners/proxies on the following outcomes: less decisional conflict/uncertainty, higher psychosocial quality of life domain (HRQL-PSY), and less regret at the time of making an anti-cancer treatment decision. The secondary aim is to evaluate the CPN role in delivery of the mHealth DA (CHAMPION) from the patients' and decision partners/proxies' perspective. Preliminary estimates of treatment effects by race to see if the data support a larger effect among African Americans versus Others in the primary and secondary aims will also be explored. This mixed-methods population-based randomized controlled trial will gather data from 158 patient/DPP pairs at three sites: University of Virginia Emily Couric Cancer Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, and Virginia Commonwealth University Massey Cancer Center. The pretest/posttest design will measure a time period that includes three single-event decisions over the course of their cancer-directed treatment; and a qualitative retrospective design will allow exploring the experiences of both patients and their DPPs separately in an interview at the completion of the study. Stratification by race (African-American and Caucasian/Other) and decision point (starting vs. changing vs. stopping anticancer treatment) will be used. There will be two groups: the control (enhanced usual care [EUC]) group and the decision intervention (DI) group. The DI group will receive an interactive 7-component cognitive-behavioral skills mHealth program (DA) with a RN-CPN team, primarily focusing on decision-making during cancer treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with DI. The primary outcome measures are 1) decisional conflict (uncertainty), 2) decisional regret, 3) HRQL-PSY, and 4) decision-making participation preference. Generalized linear models will be used for data analysis for the quantitative component, and qualitative evaluation of the intervention will be conducted to capture each pair's experience of the CHAMPION intervention. This innovative mHealth DA delivered by a CPN is expected to increase acceptability and the uptake of both the DA and the technology components. This addresses several NIH/NINR innovative questions, through the use of information technology to promote health-related decision-making for providers and patients, examining patient outcomes for improvement in healthcare, as well as to engage and support individuals such as extended family, lay coaches, etc. to augment provider care and recommendations.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth
Actual Study Start Date : July 21, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Enhanced Usual Care
Receive standard care
Experimental: Decision Intervention
Receives decision aid intervention that encompasses balance sheets, navigation, audio files, and interaction -- Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION)
 Behavioral: CHAMPION
An interactive mHealth decision aid that includes immediate and over time quality of life (QL) graphical summaries for advanced prostate cancer patients to enhance informed, shared decision making and will also be used to assess the CPNs' role in the decision-making process.


Outcome Measures
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Primary Outcome Measures :
  1. Decision Conflict, Decision Regret, and Prostate Cancer Symptom Scale [ Time Frame: 9 months ]
    demonstrate less decisional conflict/uncertainty, higher QL (HRQL-PSY domain) and less regret at the time of making an anti-cancer treatment decision


Secondary Outcome Measures :
  1. semi-structured interview [ Time Frame: 9 months ]
    evaluate community patient navigator role in delivery of decision aid


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) stages III/ IV prostate cancer 2) life expectancy ≥6 months 3) Karnofsky Performance Status >60 4) willingness of a DPP (patient selected person who provides decisional support) to participate 5) pair ages >18 years 6) ability to understand English

Exclusion Criteria:

  • severe psychiatric problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327103


Contacts
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Contact: Randy A Jones, PhD,RN,FAAN 434.924.0125 raj9c@virginia.edu
Contact: Jane Gildersleeve, MSN 434.466.8109 jlg2g@virginia.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Jennifer Wenzel, PhD,RN,FAAN    410-502-1114    jwenzel@jhu.edu   
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Randy A Jones, PhD,RN,FAAN    434-924-0125    raj9c@virginia.edu   
Contact: Jane Gildersleeve, MSN    434-243-3955    jlg2g@virginia.edu   
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Contact: Richard Brown, PhD    804-628-3340    rbrown39@vcu.edu   
Sponsors and Collaborators
University of Virginia
Johns Hopkins University
Virginia Commonwealth University
Investigators
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Principal Investigator: Randy A Jones, PhD,RN,FAAN University of Virginia
More Information
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Responsible Party: Randy A. Jones, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03327103     History of Changes
Other Study ID Numbers: 19402
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Randy A. Jones, University of Virginia:
decision making
advanced prostate cancer
decision aid
 minorities
mHealth
community patient navigator
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases